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临床试验/NCT01443884
NCT01443884已完成不适用

Anti-Inflammatory Activities of Grapes in Humans at Risk for Cardiovascular Disease

USDA, Western Human Nutrition Research Center2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2009年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
2
主要终点
Change in inflammatory mediators in serum

研究概览

简要总结

The goal of the study is to determine whether grape consumption can reduce the risk of cardiovascular disease by reducing the presence of inflammatory molecules and positively altering cholesterol levels, lipid profiles, and immune cell responses.

详细描述

Obese individuals are at high risk for the development of hypertension and cardiovascular disease. Adipose tissue is a major source of pro-inflammatory molecules which can promote the development of atherosclerosis. Development of atherosclerotic plaques are mediated by oxidized or otherwise modified LDL cholesterol and infiltration of activated immune cells into the atherosclerotic lesions. Grapes contain high levels of polyphenols, a class of compounds known to possess antioxidant and anti-inflammatory properties. The overall goal of this proposal is to determine whether grape consumption can reduce the risk of cardiovascular disease by reducing the presence of inflammatory molecules and positively altering cholesterol levels, lipid profiles, and immune cell responses. Using a randomized cross-over design, twenty obese subjects will consume beverages containing either four servings of grape powder per day or the caloric equivalent without grape powder (placebo control) for a total of three weeks. After a two week washout period, the beverages will be switched for a further three weeks. Blood will be taken from each person at six intervals to determine lipid profiles, measure inflammatory markers in plasma, and analyze immune cell responsiveness.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BMI 30 - 45 kg/m2
  • Commitment to the dietary intervention and scheduled testing

排除标准

  • Subjects will be excluded from this study if their blood cell counts or blood chemistry profiles are outside of the normal range
  • smoking or use of tobacco products
  • drink more than one alcoholic beverage per day (1 oz. distilled liquor, 3 oz. wine, or 12 oz. beer)
  • taking cholesterol-lowering medications
  • taking steroids for asthma or other inflammatory states
  • taking thyroid-regulating drugs
  • taking over-the counter weight loss products

结局指标

主要结局

Change in inflammatory mediators in serum

时间窗: 0, 1, 3, 4, 8, and 9 weeks

C-reactive protein, serum amyloid A, cytokines (IL-1, IL-6, IL-8, and TNF-a), and soluble adhesion molecules (sICAM-1, sVCAM-1) will be measured.

次要结局

  • Change in lipid particle size and quantity(0, 1, 3, 4, 8 and 9 weeks)
  • CHange in activation and proliferation of T lymphocytes(0, 1, 3, 4, 8 and 9 weeks)

研究者

发起方
USDA, Western Human Nutrition Research Center
申办方类型
Fed
责任方
Sponsor

研究点 (2)

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